Major bleeding risk low in real-world study of high-risk users of rivaroxaban

CHICAGO — A postmarketing study of nonvalvular atrial fibrillation patients taking rivaroxaban confirms that the real-world risk for major bleeding was extremely low, even in high-risk patients, researchers reported at the American College of Cardiology Scientific Session.

The results were no different than those seen in randomized controlled trials, according to the researchers.

“The risk for stroke is by far the greatest risk for these high-risk patients, not bleeding,” W. Frank Peacock, MD, FACEP, associate chair and research director, emergency medicine at Baylor College of Medicine in Houston, told Cardiology Today.

Nearly 10 million electronic medical records from the Department of Defense health care system were queried between 2013 and June 2015 to identify major bleeding-related hospitalizations among people with nonvalvular AF taking rivaroxaban (Xarelto, Janssen Pharmaceuticals) for stroke prevention.

Of the 44,793 patients identified as rivaroxaban users, nearly 27% also had diabetes. Patients with diabetes were found to have a higher rate of major bleeding compared with rivaroxaban users without diabetes (3.68 per 100 person-years vs. 2.51 per 100 person-years); however, this was consistent with findings of the ROCKET-AF pivotal trial.

Mortality related to major bleeding was rare in all users; the incidence was 0.09 per 100 person-years in those with diabetes and in those without it.

Peacock said this translated to about three of every 100 patients per year having a stroke while one-tenth of a person per 100 years was at risk from dying of a bleeding event.

“The numbers are overwhelmingly in favor of treatment. High-risk patients are the population you should be treating with rivaroxaban. You shouldn’t be holding back because you are worried they are going to bleed,” Peacock said. “All you are doing is over 100 patient years is giving 300 people a stroke to prevent one-tenth of a person from dying from a bleed.” – by Tracey Romero

Reference:

Patel MR, et al. Poster 1118-361. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.

Disclosure: The study was funded by Bayer HealthCare and Janssen Scientific Affairs. Peacock reports receiving funding from Abbott, Alere, Banyan, Cardiorentis, Portola, Roche and The Medicines Company; receiving consulting fees from Alere, BG Medicine, Beckman, Boehringer Ingelheim, Cardiorentis, Instrument Labs, Janssen, Prevencio, The Medicines Company and ZS Pharma; having ownership interests in Comprehensive Research Associates LLC and Emergencies in Medicine LLC; and serving as co-principal investigator for the MERCURY trial.